麻豆传媒

LONDON -- Data from a large multiple sclerosis patient registry suggest that alemtuzumab (Lemtrada) is more effective in key efficacy measures than two other common drugs for MS and similar in efficacy to a third, a researcher said here.

In an analysis covering some 4,500 patients who had recently started alemtuzumab, fingolimod (Gilenya), interferon-beta-1a (Rebif, Avonex), or natalizumab (Tysabri), alemtuzumab was better than fingolimod and interferon for at least one of the following outcome measures: relapse risk, disability progression, or functional improvement, and was not less effective on any efficacy measure, reported , of the University of Melbourne in Australia.

And alemtuzumab and natalizumab were in a virtual dead heat for relapse prevention and reducing disability progression, Kalincik told attendees at an oral late-breaker session during the European Committee for Treatment and Research in Multiple Sclerosis annual meeting.

There was only one outcome analyzed in the entire study for which alemtuzumab was inferior to another drug: natalizumab was more likely to produce an improvement in functional ability during the first year of treatment, though not in subsequent years.

However, the study, which was not specifically supported by any one drugmaker, had important limitations: it did not address safety at all, and the efficacy outcomes analyzed did not include effects on MRI-detected brain lesions.

Nevertheless, of the Cleveland Clinic, who was not involved with the analysis, said the data were important for informing clinicians about the real-world experience with these agents.

This type of analysis, he told 麻豆传媒, "allows us to compare drugs head-to-head that weren't compared in head to head trials, and probably won't be."

No major surprises were evident in the results, Fox said. Still, the data provide "more confidence about the emerging picture of alemtuzumab," which only gained approval less than 2 years ago.

He also pointed to a significant strength of the analysis: its use of propensity matching to make the observational study more of an "apples to apples" comparison, as he put it.

For the study Kalincik and colleagues drew on the MSbase database that currently includes some 41,000 MS patients in 35 countries treated for a cumulative 210,000 patient-years. Out of those, the researchers focused on 189 patients treated with alemtuzumab, 2,155 receiving interferon-beta-1a, 828 treated with fingolimod, and 1,160 treated with natalizumab.

To be included, patients had to meet the following criteria:

• Definite MS by standard diagnostic criteria
• New treatment with one of the four agents
• Baseline scores on the Expanded Disability Status Scale of no more than 5.5
• Age ≤65
• MS duration of <10 years
• At least one relapse in the past year
• At least 12 months of data prior to starting the drug, and at least 6 months of post-initiation follow-up
• Minimum of two post-baseline visits at least 6 months apart

Patients were also selected so that they could be matched with others with different treatment types according to clinical and demographic data (propensity matching).

Highlights of the comparisons cited by Kalincik were:

• Alemtuzumab vs interferon: superior for mitigating relapse activity and, in patients with highly active disease, disability progression; and improving functional ability
• Alemtuzumab vs fingolimod: superior for preventing relapses, otherwise comparable
• Alemtuzumab vs natalizumab: comparable for relapse activity and disability progression, natalizumab superior for early regression of disability

Kalincik said his group also performed numerous sensitivity analyses in which various parameters, such as definitions of pre-baseline disease activity, or specifying a different minimum follow-up interval, were altered. There was no important change in the overall results, he said.